Safety of Use and Efficacy of Pandora for Patients Suffering from Gonarthrosis (PANDORA2)
- Conditions
- Knee Osteoarthritis
- Registration Number
- NCT05978180
- Lead Sponsor
- Labrha
- Brief Summary
The knee osteoarthritis is a frequent degenerative condition that mainly affects subjects over 60, population often weakened by numerous comorbidities and concomitant treatments, justifying the development of new therapies.
The viscosupplementation is a symptomatic treatment for knee osteoarthritis ; the objective of this intra-articular injection of hyaluronic acid is to reduce knee pain and improve mobility. In practice, there are two protocols to administer viscosupplementation : in a single injection or in three injections performed weekly.
The present clinical investigation has the objective to evaluate the safety and efficacy of use of Pandora, a hyaluronic acid associated with tranexamic acid, in a single injection (HO-1) or in three injections performed weekly (HS-3), compared to a referred and commercialized medical device.
- Detailed Description
This clinical investigation is a prospective, multicenter, randomized, parallel groups study of a class III Medical Device.
This study is designed to compare the safety of use and the efficacy of Pandora in its two forms : in a single injection (HO-1) or in three injections (HS-3) to a single intra-articular injection of 2.5 ml (SINOVIAL®ONE)
A descriptive analysis will be carried out to characterize the demographic data, the history of the disease and its treatments, the clinical and radiological data of the patients at inclusion.
The efficacy of Pandora will be demonstrated by describing the variation of WOMAC A1 score "walking pain" of target knee in repeated measures.
In total, 252 participants will be enrolled across 40 study centers in France and Monaco.
The total duration of subjects' participation is 12 months ; overall study duration including the enrollment period is expected to take approximately 24 months.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 252
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of the two medical devices containing Pandora gel, HO-1 and HS-3, on walking pain in the target knee, compared to the SINOVIAL® ONE. 6 months Variation of the WOMAC A1 score "walking pain" of the target knee in repeated measures (weeks 4,12 and 26), between the first or single injection and the potential injection at week 26.
- Secondary Outcome Measures
Name Time Method To evaluate the efficacy of viscosupplementation by HO-1 and HS-3 on the pain of the target knee at weeks 4, 12 and 26 and week 12 as well as week 52 for patients who didn't require an injection at week 26. 12 months Variation of the pain on target knee, with repeated measures by WOMAC A score, constituted of 5 questions about knee pain, between day 1 and week 12, day 1 and week 26 as well as between day 1 and week 52 for patients who didn't require an injection of HO-1 at week 26.
To evaluate, at S52, the benefit of the additional injection of HO-1 at S26 on analgesic drug consumption. 12 months Decrease of analgesic drug consumption between week 26 and week 52 at patients receiving injection of HO-1 at week 26.
To evaluate the efficacy of viscosupplementation by HO-1 and HS-3 on walking pain of the target knee between day 1 and week 12. 3 months Variation of the WOMAC A1 score "walking pain" of the target knee between day 1 and week 12 considering the repeated measures at weeks 4 and 12.
To determine the number (and percentage) of patients requiring a new injection at S26. 6 months Number (%) of patients requiring an injection of HO-1 at week 26.
To evaluate the efficacy of viscosupplementation by HO-1 and HS-3 on the function of target knee at weeks 4, 12, 26 as well as week 52 for patients who didn't require an injection at week 26. 12 months Variation of the function , with repeated measures by the WOMAC C constituted of 17 questions, between day 1 and week 4, day 1 and week 12, day 1 and week 26 as well as between day 1 and week 52 for patients who didn't require an injection at week 26.
To evaluate the efficacy of viscosupplémentation by HO-1 and HS-3 on the analgesic drug consumption at weeks 4, 12, 26 as well as week 52 for patients who didn't require an injection at week 26. 12 months Evaluation by the patient of his analgesic drug consumption during the two weeks prior each visit.
To determine the number (and percentage) of patients "OMERACT-OARSI responsive" at weeks 4,12,26 as well as week 52 for patients who didn't require an injection at week 26. 12 months Number (%) of "responsive" patients according to OMERACT OARSI criterion, at weeks 4, 12 and 26 (and week 52 for patients who didn't require an injection at week 26).
To determine the number (and percentage) of "highly responsive" patients at weeks 4, 12 and 26 as well as week 52 for patients who didn't require an injection at week 26. 12 months Number (%) of "highly responsive" patients with a decrease of WOMAC A1 \> 50% at weeks 4, 12 and 26 (and week 52 for patients who didn't have HO-1 injection at S26).
To determine the number (and percentage) of patients in whom target knee pain is considered acceptable according to the PASS criterion at weeks 4,12 and 26 as well as week 52 for patients who didn't require an injection at week 26. 12 months Number (%) of patients reaching the threshold of PASS at weeks 4, 12 and 26 (and week 52 for patients who didn't require an injection at week 26).
To determine the number (and percentage) of patients in whom the decrease of the target knee pain is considered important (MCII criterion) at weeks 4,12 and 26 as well as week 52 for patients who didn't require an injection at week 26. 12 months Number (%) of patients whom the improvement at weeks 4, 12 and 26 (and week 52 for patients who didn't require an injection at week 26), is superior to the MCII.
To evaluate, at S52, the efficacy of the additional injection of HO-1 at S26 on pain and function of the target knee. 12 months Variation of WOMAC between week 26 and week 52 at patients receiving injection of HO-1 at week 26.
To evaluate the local tolerability (at the target knee), after each injection of HO-1 and HS-3, compared to SINOVIAL® ONE. 1 month Number of adverse events occurring, at the target knee, after each injection during the 4 weeks following the first or only one injection, whose treatments causality is not evaluated as "not related".
To assess patient's satisfaction regarding the tolerability of HO-1 treatment at week 27 for patients who received an injection at week 26. 6 months and one week (=27 weeks) Subjective assessment of tolerability by the patient, based on a 5 points numerical scale, 0 corresponding to "Very Good" and 4 "Very Bad" at week 27 for patients receiving injection of HO-1 at week 26.
To measure the self-reported treatment efficacy by the patient at weeks 4, 12, 26 and 52. 12 months Evaluation of the efficacy of the treatment by the patient based on a 11 points numerical scale (0-10) at weeks 12,26 and 52.
To assess patient's satisfaction regarding tolerability of HO-1 and HS-3 treatment between day 1 and week 4, compared to SINOVIAL® ONE. 1 month Subjective assessment of tolerability by the patient, based on a 5 points numerical scale, 0 corresponding to "Very Good" and 4 "Very Bad" at day 8, day 15 and week 4 for group's patients HO-1 and SINOVIAL® ONE.
To evaluate the global tolerability of HO-1 and HS-3 throughout the follow-up between day 1 and week 52 in comparison with SINOVIAL® ONE. 12 months Number of adverse events occurring during the 52 weeks of follow up, whose treatments causality is not evaluated as "not related".
Trial Locations
- Locations (24)
Centre de Médecine du Sport du Beaujolais
🇫🇷Arnas, France
Cabinet de Rhumatologie de Palente
🇫🇷Besançon, France
Cabinet Médical Borely Mermoz
🇫🇷Marseille, France
Clinique du Ter
🇫🇷Ploemeur, France
IM2S
🇲🇨Monaco, Monaco
Centre Médical Dulac
🇫🇷La Ciotat, France
Cabinet Médical Tilsitt
🇫🇷Lyon, France
Hôpital Nord Franche Comté
🇫🇷Belfort, France
Cabinet Médical
🇫🇷Saint-Paul-lès-Dax, France
Groupe Médical Spécialisé - Le Premium
🇫🇷Strasbourg, France
Centre de Chirurgie Orthopédique du Beaujolais
🇫🇷Arnas, France
Centre de Rhumatologie Nord Isère
🇫🇷Bourgoin-Jallieu, France
Clinique Saint Charles
🇫🇷Lyon, France
Cabinet Médical Pluridisciplinaire Wallach
🇫🇷Mulhouse, France
Groupe Hospitalier de la Haute Saône - Hôpital de Vesoul
🇫🇷Vesoul, France
Cabinet de Rhumatologie
🇫🇷Viry-Châtillon, France
Cabinet de Rhumatologie La Savoureuse
🇫🇷Belfort, France
Polyclinique des Alpes du Sud
🇫🇷Gap, France
Clinique de la Sauvegarde
🇫🇷Lyon, France
Pôle de santé des Sept Chemins
🇫🇷Vourles, France
Centre Orthopédique Santy
🇫🇷Lyon, France
Centre Médico-Social du Lac
🇫🇷Mantes-la-Jolie, France
Centre Médical Saint Roch
🇫🇷Montpellier, France
Groupe Médical Adhémar
🇫🇷Montélimar, France